Optimizing Intervention Tools to Improve Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Mean change in American Cancer Society (ACS) guideline score at 48 weeks
研究概览
简要总结
This clinical trial studies the effect of four different intervention components "tools" on body weight, nutrition, and physical activity in cancer survivors. Studies indicate that people with a history of cancer whose nutrition and physical activity habits are consistent with the American Cancer Society's Nutrition and Physical Activity Guidelines may have longer disease-free survival. The four different intervention components may help patients with a history of cancer adopt recommended health behaviors after they have completed treatment.
详细描述
PRIMARY OBJECTIVE:
I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on change cancer survivors' American Cancer Society (ACS) guideline score after 48 weeks of intervention.
SECONDARY OBJECTIVES:
I. To determine the effect of four candidate intervention components (text messaging, digital health tool kit, health coaching, or support person training), and combinations of the four intervention components, on cancer survivors' American Cancer Society (ACS) guideline score after 24 weeks of intervention.
II. To determine the effect of four candidate intervention components, and combinations of the four intervention components, on cancer survivors' intake of fruits and vegetables, whole grains, refined grains, red meat, and processed meats; moderate-to-vigorous physical activity; and body mass index (BMI) after 48 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA FOR CANCER SURVIVORS:
- •>= 18 years of age.
- •Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
- •Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments are allowed.
- •Owns a smart phone that has access to the Internet and can receive daily text messages.
- •Able to speak and read English or Spanish
- •Have a support person >= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study.
- •>= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment).
- •Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition?
- •INCLUSION CRITERIA FOR SUPPORT PERSONS:
- •Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
- •18 years of age or older.
- •Speaks and reads English or Spanish.
- •Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study.
排除标准
- •EXCLUSION CRITERIA FOR CANCER SURVIVORS:
- •People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
- •ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
- •Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit.
- •Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
- •Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments, which are allowed.
- •History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
- •History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
- •Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
- •Currently pregnant or trying to become pregnant during the study period.
- •Living outside the United States during screening and/or the 48-week study period.
- •EXCLUSION CRITERIA FOR SUPPORT PERSONS:
研究组 & 干预措施
Condition III (text, health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition XI (health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition XIV (health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Education (Behavioral)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition II (text, health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Questionnaires (Other)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Education (Behavioral)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition I (text, health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30-45 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition II (text, health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Educational Intervention (Other)
Condition II (text, health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Education (Behavioral)
Condition II (text, health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition II (text, health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition III (text, health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition III (text, health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition III (text, health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition III (text, health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition IV (text, health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
干预措施: Educational Intervention (Other)
Condition IV (text, health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition IV (text, health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition IV (text, health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages and use digital health tool kit for 48 weeks.
干预措施: Questionnaires (Other)
Condition IX (health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition IX (health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition IX (health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Education (Behavioral)
Condition IX (health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition IX (health kit, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition V (text, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition V (text, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition V (text, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Education (Behavioral)
Condition V (text, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition V (text, health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 15 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition VI (text, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Educational Intervention (Other)
Condition VI (text, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Education (Behavioral)
Condition VI (text, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition VI (text, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Questionnaires (Other)
Condition VII (text, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition VII (text, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition VII (text, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition VII (text, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition VIII (text)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks.
干预措施: Educational Intervention (Other)
Condition VIII (text)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks.
干预措施: Health Promotion and Education - Direct Text Messaging (Other)
Condition VIII (text)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive text messages for 48 weeks.
干预措施: Questionnaires (Other)
Condition X (health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Educational Intervention (Other)
Condition X (health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Education (Behavioral)
Condition X (health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition X (health kit, health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Patients also receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Questionnaires (Other)
Condition XI (health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition XI (health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition XI (health kit, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition XII (health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks.
干预措施: Educational Intervention (Other)
Condition XII (health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks.
干预措施: Health Promotion and Education - Digital health tool kit (Other)
Condition XII (health kit)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients use digital health tool kit for 48 weeks.
干预措施: Questionnaires (Other)
Condition XIII (health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition XIII (health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition XIII (health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Health Education (Behavioral)
Condition XIII (health coach, support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition XIV (health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Educational Intervention (Other)
Condition XIV (health coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Patients receive 13 health coaching sessions over 30 minutes each for 48 weeks.
干预措施: Questionnaires (Other)
Condition XV (support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Counseling (Other)
Condition XV (support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Educational Intervention (Other)
Condition XV (support coach)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer. Support persons receive four coaching sessions lasting 30 minutes each, approximately every 12 weeks for 48 weeks.
干预措施: Questionnaires (Other)
Condition XVI (study booklet)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer.
干预措施: Educational Intervention (Other)
Condition XVI (study booklet)
Patients receive a personal report comparing their nutrition and physical activity to ACS guidelines and a booklet on nutrition and physical activity for patients with a history of cancer.
干预措施: Questionnaires (Other)
结局指标
主要结局
Mean change in American Cancer Society (ACS) guideline score at 48 weeks
时间窗: Up to 48 weeks
The ACS Guideline Score is comprised of scores on participant reported food intake (score range from 0-2), physical activity (score range from 0-2), and body mass index (BMI) (score range from 0-2). The total score is calculated by summing the scores on each component with a total score range from 0 to 6. Greater scores indicate a greater level of healthy choices made by the participant. The investigator will assess the independent and interaction effects of the four treatment components on change in ACS score as repeated measures and using a generalized linear mixed effect model, starting with the saturated model, including coefficients for main effects, interactions up to 3-way, and stratification variables (gender and age), and reduce the model via backward variable selection with a 0.05 significance level (alpha(α)=0.05) up to 48 weeks.
次要结局
- Mean change in scores on the individual components of the ACS at 24 weeks(Up to 24 weeks)
- Mean change in ACS guideline score at 24 weeks(Up to 24 weeks)
- Mean change in scores on the individual components of the ACS at 48 weeks(Up to 48 weeks)
