Design and Integration of a Survivorship Nutrition Intervention Into an Established Exercise Oncology Program: the BfedBwell Pilot Intervention
概览
- 阶段
- 不适用
- 干预措施
- Group-based education and discussion
- 疾病 / 适应症
- Cancer Survivorship
- 发起方
- University of Colorado, Denver
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell).
详细描述
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell + BfitBwell intervention. Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 12-week single-arm study of the integrated BfedBwell + BfitBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to evaluate proof-of-concept prior to advancing to efficacy testing.
研究者
入排标准
入选标准
- •For program delivery staff:
- •Men and women
- •Age ≥ 18 years
- •Speak English
- •Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs
- •For intervention participants:
- •Men and women
- •Age 18-75 years
- •Body Mass Index 25-45 kg/m2
- •Completion of active cancer therapy with curative intent at least three months and no more than five years prior to enrollment; ongoing hormone therapy is permitted
排除标准
- •Willing to attend weekly small group sessions (behavioral skills development and/or group support) and/or 1:1 counseling held by a registered dietitian (RD) and attend up to two BfitBwell exercise sessions per week
- •Not meeting dietary guidelines \[i.e., Healthy Eating Index (HEI) score \<80 as assessed via National Cancer Institute Diet History Questionnaire III (NCI DHQ III) food frequency questionnaire\] or physical activity guidelines \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\]
- •Exclusion Criteria:
- •For program delivery staff:
- •For intervention participants:
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
- •Actively undergoing cancer therapy or within 3 months of completion of surgery, chemotherapy, or radiation treatment
- •Greater than 5 years post-active therapy
- •Plans to relocate within the next 6 months
- •Plans for extended travel (\>2 weeks) within the next 6 months
研究组 & 干预措施
Cancer Survivors
Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.
干预措施: Group-based education and discussion
Cancer Survivors
Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.
干预措施: Individual 1:1 counseling
Cancer Survivors
Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.
干预措施: Group based behavioral skills development and cooking demonstrations
Cancer Survivors
Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.
干预措施: BfitBwell
结局指标
主要结局
Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
时间窗: 12 weeks
Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness.
Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention
时间窗: 12 weeks
Adherence will be assessed as \[# sessions attended/# sessions provided\]
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
时间窗: 12 weeks
Retention will be assessed as \[# of participants who complete the 12-week intervention/# of participants enrolled\].
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
时间窗: 12 weeks
Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability.
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
时间窗: 12 weeks
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll.
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
时间窗: 12 weeks
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\].
Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
时间窗: 12 weeks
Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility.
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
时间窗: 12 weeks
Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters - % detractors. NPS scores range from -100 to +100, with scores \>0 indicating good acceptability.
Determine the intervention acceptability by participants and program providers during qualitative interviews
时间窗: 12 weeks
1:1 interviews will be conducted with all program delivery staff and BfedBwell survivorship nutrition intervention participants after the 12-week intervention to assess acceptability of intervention and provide feedback for continued refinement.
次要结局
- Measure the change in systolic blood pressure to determine improved cardiometabolic health(12 weeks)
- Measure changes in HDL cholesterol to determine improved cardiometabolic health(12 weeks)
- Intervention safety determined by number of adverse events(12 weeks)
- Measure changes in triglycerides to determine improved cardiometabolic health(12 weeks)
- Measure changes in glucose to determine improved cardiometabolic health(12 weeks)
- Measure changes in insulin to determine improved cardiometabolic health(12 weeks)
- Assess preliminary efficacy for increased adherence to lifestyle recommendations(12 weeks)
- Assess preliminary efficacy for weight loss(12 weeks)
- Measure the change in diastolic blood pressure to determine improved cardiometabolic health(12 weeks)
- Measure changes in total cholesterol to determine improved cardiometabolic health(12 weeks)
- Measure changes in LDL cholesterol to determine improved cardiometabolic health(12 weeks)
- Assess preliminary efficacy for improvement in body composition(12 weeks)