Advanced (unresectable and/or metastatic) colorectal cancer undergoing chemotherapy Cancer
Conditions
Interventions
12-week physical activity and nutrition programming with weekly face-to-face sessions with a physical activity and nutrition coach with a focus on strength training and increasing protein intake.
Sponsors
Queen's University Belfast
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Main participants: 1. Age of at least 18 years. 2. Histologically-confirmed unresectable Stage III or Stage IV adenocarcinoma of the colon or rectum. 3. Planned for systemic anti-cancer treatment (SACT) with a 5-flourouracil-based regimen with palliative intent. 4. Greater than 12 weeks from any prior SACT. 5. Greater than 4 weeks from any prior major surgery and fully recovered. 6. ECOG performance status 0-2 and anticipated life expectancy greater than 4 months. 7. Adequate haematological, renal and hepatic function to undergo standard of care SACT as assessed by treating oncologist. 8. Medical clearance by treating physician to undergo symptom-limited muscle strength testing, physical function testing, and tailored resistance-based exercise training. 9. Ability (i.e. sufficiently fluent) and willingness to effectively communicate with the Physical Activity and Nutrition Coach. 10. Willingness to eat an unrestricted diet. Includes participants willing to eat an otherwise unrestricted vegetarian diet. 11. Ability to provide written informed consent. Nominated friend/family members (for questionnaires and interview): 1. One person nominated by the main study participant. 2. Ability to provide written informed consent. Healthcare professionals involved in study (for interview). 1. Ability to provide written informed consent. Potential participants who decline to participate (for interview): 1. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Significant cognitive impairment or co-morbid conditions precluding participation in a resistance-training programme as determined by the investigator. 2. Peripheral neuropathy > grade 2. 3. Unlikeliness to participate in a physical activity and nutrition intervention as determined by the investigator. 4. Patients undergoing adjuvant-intent chemotherapy in the setting of radically treated oligometastatic hepatic disease. 5. Concurrent treatment for a second malignancy. 6. Treatment with any medications deemed by the investigator as likely to preclude participation in a resistance-training programme. 7. Individual already participating in structured resistance-training = 2 days per week. No specific exclusion criteria for nominated friends/family members, healthcare professionals, and non-participants taking part in questionnaires and interviews.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate – measured by record of number of participants enrolled as a proportion of number of eligible participants approached about study, and by recorded time to recruit to target (20 participants). Reason for participation and non-participation will be explored qualitatively with semi-structured interviews. 2. Retention – measured by drop-out rate of enrolled participants prior to intervention completion and final assessments, this will include descriptive record of number of sessions attended prior to drop-out. Reasons for drop-out will be explored qualitatively in semi-structured interviews. 3. Adherence to intervention – measured objectively by record of number of planned face-to-face sessions attended by participants, and subjectively by description of self-reported adherence to home physical activity and nutrition prescription as recorded in participant booklet and recorded by the researcher on case report forms during weekly face-to-face sessions. 4. Acceptability of intervention – assessed by thematic analysis of semi-structured qualitative interviews with 5-10 participants (until data saturation). Eligible participants who decline to participate will be invited to discuss rationale for this. Nominated friends and family members of participants will also be invited to semi-structured interviews about their experience of supporting someone participating in the study. Healthcare professionals involved in the study will also be invited to interviews to discuss the acceptability of the intervention. All interviews will undergo thematic analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle mass measured using cross-sectional area of muscle at L3 on standard-of-care CT and by bioimpedance analysis at baseline and after 12-week programme. 2. Muscle strength measured by handgrip strength and repetition maximal testing at baseline and after 12-week programme. 3. Physical function measured by six-minute walk test and 30 second sit-to-stand at baseline and after 12-week programme. 4. Participant reported physical activity measured by IPAQ-SF and MSEQ-SF questionnaires at baseline and after 12-week programme. 5. Protein and calorie intake estimated from self-reported three day food diaries at baseline and after 12-week programme. 6. Participant reported quality-of-life measured by QLQ-C30 questionnaire at baseline and after 12-week programme. 7. Nominated friend/family member of participant reported quality of life measured by SF-36 questionnaire at baseline and after 12-week programme. 8. Safety of intervention as assess by description of intervention-associated adverse events recorded during face-to-face sessions. 9. Qualitative thematic analysis of experience of intervention (in participants, nominated friend/family members and healthcare professionals) and reasons for non-participation (in patients approached who decline to participate). 10. Assessment of chemotherapy response as measured by RECIST v1.1 criteria on standard-of-care response CT 11. Collection of longitudinal blood samples and access to historic tumour biopsy samples for exploratory cancer biomarker research | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactVicky;David Coyle;Burke
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Outcome results
None listed