A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment inadolescents and young adults

Phase 2

Recruiting

• Conditions: Cancer; Cancer - Any cancer; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12615000527561
• Lead Sponsor: Australian and New Zealand Children's Haematology and Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants must be aged between 15 and 25 years of age
- Diagnosed with a haematological malignancy or solid tumour
- Completed systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation).
- Cancer therapy completed within the previous two months (or have started maintenance therapy for acute lymphoblastic leukaemia (or lymphoblastic lymphoma) within the past two months)
- Medically stable (as determined by a medical practitioner) and written clearance from a doctor in their treating team to undertake a progressive exercise program.

Exclusion Criteria

- Cognitive impairment (determined by a medical practitioner)
- Patients who undergo surgery only
- <6 months life expectancy
- Absolute contraindications to exercise e.g. unstable angina, uncontrolled heart failure, acute systemic infection accompanied by fever.
- Insufficient English to participate in the exercise programme and exercise assessments, or to complete the questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness) [10 weeks after commencement of the exercise intervention];Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)[10 weeks after commencement of the exercise intervention];Fatigue score (as measured by FACIT fatigue scale)[10 weeks after commencement of the exercise intervention]

Secondary Outcome Measures

Name	Time	Method
Functional capacity (as measured by Cardiopulmonary exercise testing / VO2 max and other standardised measures of fitness) [6 months after commencement of the exercise intervention];Quality of Life (as measured by AQoL-6D, EORTC-C30, FACT-G, Peds-QL (AYA modification)[6 months after commencement of the exercise intervention];Fatigue Score (as measured by FACIT-fatigue scale)[6 months after commencement of the exercise intervention];Participation in physical fitness activities (as measured by Godin Leisure Time Exercise questionnaire)[6 months after commencement of the exercise intervention]