Colorectal cancer Cancer Colorectal cancer
Conditions
Interventions
The intervention for this study is joint physical activity consultations. Physical activity consultations involve face-to-face discussions and include, for example, assessment of current levels of phy
one at 3 weeks and one at 7 weeks (4 in total throughout their participation in the study).
Couples in the control arm of the trial will receive usual care. This involves a follow up appointment at t
Sponsors
University of Stirling (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individual living with colorectal cancer: 1. Initial diagnosis Dukes stage A-C2 colorectal cancer with no current evidence of metastatic disease 2. Aged 18 years or older, either sex 3. Have completed surgery in the last 24 months 4. Not currently undergoing surgery or adjuvant chemotherapy and/or radiation therapy for cancer 5. Has a partner 6. Not currently meeting national physical activity guidelines (of 30 minutes moderate-intensity activity five times per week) 7. Able to communicate in English Partner: 1. Partner of individual living with colorectal cancer included in the study 2. Aged 18 years or older 3. Not currently undergoing surgery or adjuvant chemotherapy and/or radiation therapy for cancer 4. Able to communicate in English
Exclusion criteria
Exclusion criteria: Individual living with colorectal cancer: 1. Initial diagnosis Dukes stage D 2. Evidence of metastatic disease 3. Suffers from unstable cardiac or respiratory disease (due to inappropriateness of physical activity intervention) 4. Partner is unwilling to participate in study 5. Currently undergoing surgery or adjuvant chemotherapy and/or radiation therapy for cancer 6. Currently achieving national physical activity guidelines 7. Unable to communicate in English Partner: 1. Currently undergoing surgery or adjuvant chemotherapy and/or radiation therapy for cancer 2. Suffers from unstable cardiac or respiratory disease (due to inappropriateness of physical activity intervention) 3. Unable to communicate in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will be measured by calculating the following rates: 1. Recruitment rate (number of participants randomised/number of eligible participants) 2. Completion rate (number of participants completing baseline and 6 month intervention assessments/number of participants randomised) 3. Adherence rate (number of physical activity consultations and telephone calls conducted/number of physical activity consultations and telephone calls scheduled) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in physical activity will be measured from baseline to 3 and 6 months follow-up in individuals living with colorectal cancer and their partner. Physical activity will be assessed for 7 consecutive days at each time-point using the Actigraph GT1M-Plus accelerometer (Actigraph LLC, Pensacola, Florida). Monitors will be attached to adjustable elastic belts and worn over the right hip under clothing during all waking hours. The raw accelerometry output (accelerometer count per minute [cpm], averaged over the monitoring period) will be used as a measure of total physical activity and will also be used to quantify the amount of monitored time spent in sedentary behaviour and moderate and vigorous physical activity using validated cut off points. Physical activity will also be assessed subjectively using the long (self-report) version of the International Physical Activity Questionnaire (IPAQ) to ascertain the types of activities participants engaged in as this information is not provided by the accelerometers. This questionnaire measures time spent in moderate and vigorous activity across four domains (work, transport, housework/gardening and leisure time) and time spent sitting in the previous 7 days. 2. Mental well-being will be measured at baseline, 3 and 6 months using the Hospital Anxiety and Depression (HADS) Scale (0 = Not at all, 4 = Most of the time). This is a brief, self-report questionnaire used to measure state anxiety and depression over the past week. 3. Quality of life in people living with colorectal cancer will be measured at baseline, 3 and 6 months using the Functional Assessment of Cancer Therapy C General (FACT-G) questionnaire. The latest version 4 is formulated into separate subscales: physical, emotional, social/family and functional well-being. The Functional Assessment of Cancer Therapy C Colorectal (FACT-C), which includes additional concerns for colorectal cancer patients, will also be used. Both scales questions are scored 0 = Not | — |
Countries
United Kingdom
Outcome results
None listed