Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors (NCT02647021) | Clinical Trial Compass
CompletedNot Applicable
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors
Canada60 participantsStarted 2016-03-31
Plain-language summary
The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
* Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
* Presenting with shoulder and/ or neck dysfunction related to cancer treatment
* Karnofsky Performance Status greater than or equal to 60%
* No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
* Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
* Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.
Exclusion Criteria:
* A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire