Investigation into the impact of a physical activity health promotion pack on the wellbeing of people living with cancer
| ISRCTN | ISRCTN66418871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66418871 |
| Secondary identifying numbers | MoveMoreRCT |
- Submission date
- 25/07/2017
- Registration date
- 26/07/2017
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The aim of this study is to understand the impact of health promotion information on the wellbeing of people living with cancer. This study will compare the provision of guidelines, and provision of a health promotion pack to support people living with cancer to change a lifestyle behaviour. This study will allow for a greater understanding of the needs of people living with cancer, and how health promotion information can be better designed, developed, and distributed in the future.
Who can participate?
Adults aged 18 and older who are living with cancer.
What does the study involve?
This is a two arm, waiting list control study with embedded process evaluation. Participants in the control arm are sent, in the mail, the physical activity guidelines for people living with cancer. Participants in the intervention arm will be sent, in the mail, a printed physical activity health promotion pack, and directed to online tools, as well as receiving four e-newsletters over 12 weeks. Data will be collected via online survey on physical activity, self efficacy and quality of life at baseline, and at 12 weeks follow up. The intervention group is followed up again at 24 weeks with the same measures collected. The control arm receives the intervention at 12 weeks and is followed up again at 24 weeks. Use of the physical activity health promotion pack is assessed as part of the online survey administered to the intervention group at 12 weeks. Participants from the intervention arm are split into two groups, those inactive before their cancer diagnosis, and those active before their cancer diagnosis. Initially five participants from each of these group are randomly allocated to take part in a phone interview to gain a deeper understanding of their interaction with, and views of, the physical activity health promotion pack. Additional interviews are conducted if new themes are still emerging following these initial phone interviews.
What are the possible benefits and risks of participating?
There are no direct benefits with participating. Participants may find answering questions regarding their cancer distressing, and if so, they will be directed to the support that they need. Participants will be provided with additional information to consider before making any changes to their lifestyle, to ensure that it is right for them.
Where is the study run from?
University of Surrey (UK)
When is the study starting and how long is it expected to run for?
October 2016 to October 2018
Who is funding the study?
Investigator initiated and funded (UK)
Who is the main contact?
Justin Webb
justin.webb@surrey.ac.uk
Contact information
Public
University of Surrey
Guildford
GU2 7XH
United Kingdom
Study information
| Study design | This is a two arm, waiting list control study with embedded process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A randomised waiting list control trial, with embedded process evaluation, to investigate the impact of a physical activity health promotion pack on the wellbeing of people living with cancer |
| Study objectives | Hypothesis: A physical activity health promotion pack will improve physical activity levels in people living with cancer over provision of the physical activity guidelines. Primary study aim: The primary aim of this study is to test the effectiveness of a physical activity health promotion pack in moving people living with cancer categorised as ‘inactive’ or ‘moderately active’, to ‘active’. Secondary study aims: 1. Testing the impact of the physical activity health promotion pack on the quality of life of people living with and beyond cancer 2. Sub group analysis to understand for whom the physical activity health promotion pack positively impacts upon physical activity and quality of life, in the context of pre-diagnosis levels of physical activity, and self-efficacy 3. A process evaluation to further understand the mechanisms for change |
| Ethics approval(s) | University of Surrey Ethics Committee, 15/03/2017, ref: UEC/2017/023/FHMS |
| Health condition(s) or problem(s) studied | People living with cancer |
| Intervention | Participants are randomised using simple randomisation (toss of a coin) to either the intervention or the control group. Intervention arm: A printed physical activity health promotion pack sent in the mail, supported by an online forum with patients and cancer specialist physiotherapist, online video case studies, and four e-newsletters sent to participants email accounts over 12 weeks. Control: The guidelines for physical activity, sent in the mail. This is a two arm, waiting list control study with embedded process evaluation. Participants in the control arm are sent, in the mail, the physical activity guidelines for people living with cancer. Participants in the intervention arm are sent, in the mail, a printed physical activity health promotion pack, and directed to online tools, as well as receiving four e-newsletters over 12 weeks. Data is collected via online survey on physical activity, self efficacy and quality of life at baseline, and at 12 weeks follow up. The intervention group will be followed up again at 24 weeks with the same measures collected. The control arm will receive the intervention at 12 weeks and will be followed up again at 24 weeks. Use of the physical activity health promotion pack will be assessed as part of the online survey administered to the intervention group at 12 weeks. Participants from the intervention arm will be split into two groups, those inactive before their cancer diagnosis, and those active before their cancer diagnosis. Initially five participants from each of these group will be randomly selected to take part in a phone interview to gain a deeper understanding of their interaction with, and views of, the physical activity health promotion pack. Additional interviews will be conducted if new themes are still emerging following these initial phone interviews. |
| Intervention type | Behavioural |
| Primary outcome measure | Physical activity levels are measured using the Godin Leisure-Time Exercise Questionnaire at baseline, 12weeks, and 24 weeks. |
| Secondary outcome measures | 1. Quality of life is measured using the FACT-G7 questionnaire at baseline, 12weeks, and 24 weeks 2. Self-efficacy is measured using a single-item measure based on a previous study (Kampshoff, van Mechelen, Schep, Nijziel and Witlox et al. (2016)) at baseline, 12weeks, and 24 weeks |
| Overall study start date | 01/10/2016 |
| Completion date | 31/10/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 164 |
| Total final enrolment | 104 |
| Key inclusion criteria | 1. People living with cancer 2. Aged 18 or over 3. Who can read English 4. Able to provide consent 5. Have an active e-mail account |
| Key exclusion criteria | 1. Those less than eight weeks post-surgery 2. Those experiencing extreme fatigue, anaemia or severe balance and coordination problems 3. Those with cancer in your bones, or bone thinning 4. Those with a heart or lung condition 5. Those experiencing pain in their chest at rest, during daily activities or when becoming active 6. Those experiencing persistent pain in their muscles, bones or joints 7. Those with swelling or inflammation in the abdomen, groin, or lower extremity 8. Those who have been informed by a doctor to only do medically supervised physical activity |
| Date of first enrolment | 20/03/2017 |
| Date of final enrolment | 01/03/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guildford
GU2 7XH
United Kingdom
Sponsor information
University/education
388 Stag Hill
Guildford
GU2 7XH
England
United Kingdom
| Website | www.surrey.ac.uk |
|---|---|
"ROR" |
https://ror.org/00ks66431 |
Funders
Funder type
Not defined
No information available
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Macmillan, Society for the Prevention and Relief of Cancer, Cancer Relief Macmillan Fund, Macmillan Cancer Relief, MCS
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of the protocol in the Journal of Medical Internet Research (JMIR). It is planned to publish the study results in a high-impact peer reviewed journal, with further dissemination at relevant conferences, such as the National Cancer Research Institute conference. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2019 | 21/06/2019 | Yes | No |
Editorial Notes
21/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
16/01/2018: The Plain English summary has been added.
16/10/2017: Internal review.
11/08/2017: Internal review.
