Trial Outcomes & Findings for Diet and Physical Activity in Uterine Cancer Survivors (NCT NCT02433080)
NCT ID: NCT02433080
Last Updated: 2020-05-19
Results Overview
Achieving a 30% recruitment rate of the potentially eligible participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-19
Participant Flow
Although 60 participants were enrolled, only 54 were included in the study analysis as the remaining 6 participants were deemed ineligible to participate and excluded from the analysis.
Participant milestones
| Measure |
Shape-Up Following Cancer Treatment
In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.
Shape-Up following cancer treatment: The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.
|
Control Intervention
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
8 Weeks
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Shape-Up Following Cancer Treatment
In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.
Shape-Up following cancer treatment: The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.
|
Control Intervention
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Diet and Physical Activity in Uterine Cancer Survivors
Baseline characteristics by cohort
| Measure |
Shape-Up Following Cancer Treatment
n=25 Participants
In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.
Shape-Up following cancer treatment: The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Of the 296 potentially eligible participants, 20.3% were enrolled in the study.
Achieving a 30% recruitment rate of the potentially eligible participants
Outcome measures
| Measure |
Both Arms Combined
n=296 Participants
Recruitment to the trial overall
|
Control Intervention
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)
|
20.3 percentage of participants
Interval 15.7 to 24.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeksEuropean Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 \& European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module 24 Global quality of life scale ranging from 0-100 with higher scores indicating better quality of life
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life Score
8week change from baseline
|
3.0 units on the global QoL scale 0-100
Standard Deviation 11.3
|
8.7 units on the global QoL scale 0-100
Standard Deviation 14.5
|
|
Change From Baseline in Health-related Quality of Life Score
24week change from baseline
|
8.7 units on the global QoL scale 0-100
Standard Deviation 14.5
|
-1.4 units on the global QoL scale 0-100
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeksPopulation: The outcome measure values below refer to the change at 24weeks from baseline using an ANCOVA model
One 24-h dietary recall for each timepoint. This is the combined total Alternate healthy eating index-2010 score ranging from 0-110 with higher scores indicating higher dietary quality.
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Dietary Quality (24-h Dietary Recall)
8week change from baseline
|
4.4 units on a scale (AHEI-2010)
Standard Deviation 15.3
|
-2.9 units on a scale (AHEI-2010)
Standard Deviation 14.1
|
|
Change From Baseline in Dietary Quality (24-h Dietary Recall)
24week change from baseline
|
3.0 units on a scale (AHEI-2010)
Standard Deviation 14.0
|
2.2 units on a scale (AHEI-2010)
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeks7-day physical activity recall
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Physical Activity (Physical Activity Recall)
8week change from baseline
|
-1.4 MET-h/day
Standard Deviation 2.2
|
-1.8 MET-h/day
Standard Deviation 3.6
|
|
Change From Baseline in Physical Activity (Physical Activity Recall)
24week change from baseline
|
0.2 MET-h/day
Standard Deviation 2.1
|
0.4 MET-h/day
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeksOutcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Hand-grip Strength
8week change from baseline
|
-0.3 kg
Standard Deviation 2.4
|
-1.7 kg
Standard Deviation 3.1
|
|
Change From Baseline in Hand-grip Strength
24week change from baseline
|
0.0 kg
Standard Deviation 2.4
|
-1.3 kg
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeksOutcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Weight
8week change from baseline
|
-0.9 kg
Standard Deviation 1.1
|
0.3 kg
Standard Deviation 1.5
|
|
Change From Baseline in Weight
24week change from baseline
|
-1.1 kg
Standard Deviation 2.6
|
-0.2 kg
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 8weeks, 24weeksUsing MC980 multi-frequency segmental body composition analyser. Fat mass index was calculated as kg of fat mass divided by squared height in meters.
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Change From Baseline in Fat Mass Index
8week change from baseline
|
-0.1 kg/m2
Standard Deviation 0.8
|
0.1 kg/m2
Standard Deviation 0.5
|
|
Change From Baseline in Fat Mass Index
24week change from baseline
|
-0.4 kg/m2
Standard Deviation 0.8
|
-0.2 kg/m2
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 8weeks, 24weeksPopulation: Missing data for 2 people in the Shape-up group
Change in the self-assessment of the gained skills (Shape-Up self-efficacy score). This is a total score 0-5 with higher scores indicating higher self-efficacy.
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Intervention Evaluation Questionnaire
8week change from baseline
|
0.2 units on a scale 0-5
Standard Deviation 0.5
|
-0.2 units on a scale 0-5
Standard Deviation 0.7
|
|
Intervention Evaluation Questionnaire
24week change from baseline
|
0.1 units on a scale 0-5
Standard Deviation 0.5
|
-0.1 units on a scale 0-5
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 24weeksNumber of currently prescribed medications over the 24 weeks of the trial (Self-reported)
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Health Care Services Use - Medication
|
1.4 Prescribed medications
Standard Deviation 2.2
|
1.5 Prescribed medications
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 8 weeksThe percentage of engaged participants attending at least one of the last three sessions of the intervention. Engaged participants are those who have attended at least two sessions of the intervention.
Outcome measures
| Measure |
Both Arms Combined
n=26 Participants
Recruitment to the trial overall
|
Control Intervention
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Adherence Rate
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24weeksRate of complete follow-up
Outcome measures
| Measure |
Both Arms Combined
n=26 Participants
Recruitment to the trial overall
|
Control Intervention
n=28 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Retention Rate
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 24weeksNumber of visits to their general practitioner over the 24 weeks of the trial (Self-reported)
Outcome measures
| Measure |
Both Arms Combined
n=25 Participants
Recruitment to the trial overall
|
Control Intervention
n=24 Participants
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Health Care Services Use - Number of General Practitioner Visits
|
1.2 Visits to the general practitioner
Standard Deviation 1.8
|
1.5 Visits to the general practitioner
Standard Deviation 1.7
|
Adverse Events
Shape-Up Following Cancer Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Shape-Up Following Cancer Treatment
n=26 participants at risk
In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called "Shape-Up following cancer treatment: a self-help programme on eating well and being active". Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group.
Shape-Up following cancer treatment: The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.
|
Control Intervention
n=28 participants at risk
Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment.
During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet "Healthy living after cancer"; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer diagnosis
|
0.00%
0/26 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
3.6%
1/28 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer recurrence
|
0.00%
0/26 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
3.6%
1/28 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/26 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
3.6%
1/28 • 24 weeks
Denominators in the adverse event rates below denote number of participants included in the study analysis excluding ineligible participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place