Feasibility of A Co-designed Lifestyle Intervention during Treatment for Advanced colorecTal cancEr: a single centre pilot study.

Queen's University Belfast0 个研究点目标入组 60 人开始时间: 2024年3月26日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•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.

•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.

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