Community for Physical Activity and Supportive Nutrition Strategies (COMPASS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accrual (Acceptability)
研究概览
简要总结
This clinical trial studies whether a tailored, web-based program (web portal), Community for Physical Activity and Supportive Nutrition Strategies (COMPASS), can be used to improve exercise and dietary changes in patients with stage I-III pancreatic cancer who are receiving chemotherapy before surgery (neoadjuvant). Pancreatic cancer is a rare and understudied cancer, particularly in the area of promoting a healthy lifestyle to preserve physical and mental well-being during a long and difficult treatment regimen. Since pancreatic cancer is rare, programs have limited resources available to reach the patients who could benefit from programs aimed at promoting exercise and a healthy diet. The COMPASS web-portal is easily accessed by the patient via a computer, tablet, or phone. It is tailored to the unique needs of pancreatic cancer patients and provides exercise and diet recommendations along with behavioral support as they undergo the long process of cancer therapy. This may be a more effective way to reach and engage with the patient, which may improve exercise and dietary changes in stage I-III pancreatic cancer patients receiving neoadjuvant chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. Acceptability of the COMPASS web portal will be assessed through accrual, study retention, end-of-study focus groups, and exit surveys, while feasibility will be measured by adherence to prescribed recommendations, frequency of portal visits, and aggregate web portal usage data.
SECONDARY OBJECTIVE:
I. To evaluate the preliminary effectiveness of COMPASS on exercise and diet habits, self-efficacy for behavior change, stages of change for exercise, changes in physical and mental well-being, and treatment tolerance (treatment-related symptoms, side effects, # of dose reductions) at baseline, 3 months and post chemotherapy.
TERTIARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age 18 years or older on date of enrollment
- •Confirmed by review of the date of birth as documented in the electronic medical record (EMR) and subsequently recorded in a case report form (CRF)
- •Diagnosed with stage I-III pancreatic cancer
- •Confirmed by EMR review. In cases where the EMR is unclear, their physician will be contacted and asked to confirm
- •Scheduled to receive neoadjuvant chemotherapy at Oregon Health & Science University (OHSU)
- •Confirmed by EMR review. In cases where the EMR is unclear, their physician will be contacted and asked to confirm
- •Willing to adhere to the study protocol
- •Confirmed verbally with the participant and response documented in the Participant Tracking database
排除标准
- •Cognitive difficulties that preclude answering the survey questions, participating in the intervention, or giving informed consent
- •In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance or professional opinion of the Principal Investigators, Dr. Kerri Winters-Stone and/or Dr. Jackilen Shannon
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in light intensity exercise
- •Confirmed by a combination of reviewing the EMR, and self-report during the initial screening call. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone or Dr. Jackilen Shannon, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible
- •Not fluent in English and therefore incapable of answer survey questions, reading the intervention web portal, and providing informed consent in English
- •Confirmed verbally with the participant and response documented in the Participant Tracking database
研究组 & 干预措施
Group 1 (COMPASS + brief coaching support)
Participants receive access to COMPASS portal, a tailored exercise intervention which may consist of strength, aerobic, balance, and flexibility exercises, and tailored diet recommendations for the duration of neoadjuvant chemotherapy. Participants also receive an initial coaching call to discuss the tailored exercise intervention and dietary recommendations and may optionally receive motivational and support text messages TIW on study.
干预措施: Physical Activity and Nutritional Recommendations and Support (Behavioral)
Group 2 (COMPASS + enhanced coaching support)
Participants receive the same intervention as Group 1, but receive additional monthly coaching support
干预措施: Physical Activity and Nutritional Recommendations and Support (Behavioral)
结局指标
主要结局
Accrual (Acceptability)
时间窗: Up to 12 months
Accrual will be measured by the number of eligible patients who enroll in the study divided by the total number approached for recruitment. Successful accrual will be defined as recruiting 30 pancreatic cancer patients
Study retention (Acceptability)
时间窗: Up to 12 months
Measured by the number of participants who enroll and complete the study intervention during their neoadjuvant chemotherapy treatment. Successful retention will be if 80% (24) participants complete the study's intervention while in neoadjuvant chemotherapy.
Listening session
时间窗: At completion of neoadjuvant chemotherapy (average of 6 months)
A minimum of 2 and maximum of 4 virtual listening sessions, at least one of men and one of women will be conducted. Each group will consist of 8-10 individuals and will explore questions of ease of use, whether they felt the portal was engaging and effectively encouraged positive behaviors. Information will also be sought about how the portal may be improved.
Exit survey
时间窗: At completion of neoadjuvant chemotherapy (average of 6 months)
This survey will assess which parts of the web portal and intervention participants felt were most useful. The survey includes questions about each component of the web portal and intervention, with responses ranging from "Strongly Disagree" to "Strongly Agree," as well as open-ended questions that allow participants to provide additional thoughts or comments about the web portal.
Study intervention adherence (Feasibility)
时间窗: Up to 12 months
Adherence will be defined as the proportion of participants who achieve at least one prescribed weekly exercise goal or nutrition recommendation during ≥80% of the weeks of their neoadjuvant chemotherapy period. Values range from 0% to 100%, with higher percentages indicating greater adherence to the study intervention.
Web portal visit frequency (Feasibility)
时间窗: Up to 12 months
Will be measured by the number of times participants logged into the web portal during the intervention period.
Web portal aggregate activity (Feasibility)
时间窗: Up to 12 months
The number of clicks on specific web portal components, most frequently visited web pages, average time spent on the web portal and on different sections, time spent logging information or syncing Fitbit data
次要结局
- Change in self-report physical activity behavior(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in dietary behavior(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in objectively measured physical activity (kcal/week)(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in objectively measured physical activity (daily step count)(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in Self-efficacy for Exercise score(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in stages of change for exercise(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Healthy Eating and Weight Self-Efficacy(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in self-report physical functioning, quality of life, and cancer related symptoms(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Symptom Measures(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in cognitive function(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in neuropathy(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in pain(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Change in treatment dosing(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
- Incidence of adverse events(At baseline, 3 months, and the completion of neoadjuvant chemotherapy up to 12 months)
研究者
Kerri Winters
Professor
OHSU Knight Cancer Institute