Improving symptoms and quality of life in women who have been treated for cervical cancer Signs and Symptoms
Conditions
Interventions
This feasibility trial aims to implement and evaluate a 12-week intervention programme to increase physical activity in women who have been treated for cervical cancer. A mixed-methods design will be
Sponsors
Loughborough University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who are at least 6 months post-treatment for cervical cancer 2. Women who are between the ages of 18-60 years 3. Women who do not meet the national guidelines for physical activity (150 minutes of moderate-intensity physical activity)
Exclusion criteria
Exclusion criteria: 1. Women who have been treated for abnormal/pre-cancerous cells only 2. Women who are unable to be physically active for a medical reason which is unrelated to their cervical cancer diagnosis and treatment 3. Women under active follow up who do not have relevant approval from the consultant gynaecologist 4. Where a firm grasp of the English language is not evidenced
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility aspects of the trial, measured via: 1. Recruitment rate: the number of participants who are recruited, represented as a percentage of the number of women who show interest, measured at baseline 2. Attrition rate: the percentage of participants who withdraw after completing baseline measurements, measured at 6 months 3. Retention rate: the percentage of participants who complete all programme components and evaluation measurements, measured at 6 months 4. Compliance rates: represented by 4.1. Percentage of participants who fully comply with wearing the research-grade accelerometer, measured at 6 months 4.2. Percentage of participants who complete the study questionnaires at baseline, 6 weeks, 12 weeks and 6 months 4.3. Percentage of women who engage with the 6 health coaching sessions (telephone calls), measured at 6 months 4.4. Percentage of participants who complete diary entries, measured at 6 months 4.5. Percentage of participants who take part in group walks and the frequency of these, measured at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Minutes of physical activity, measured using accelerometer at baseline, 6 weeks, 12 weeks and 6 months 2. Minutes of moderate-intensity activity measured using accelerometer at baseline, 6 weeks, 12 weeks and 6 months 3. Menopausal symptoms measured using the Menopausal Rating Scale at baseline, 6 weeks, 12 weeks and 6 months 4. Quality of life measured using the European Organisation for Research and Treatment of Cancer QOL measure (EORTC QLQ-30) at baseline, 6 weeks, 12 weeks and 6 months 5. Symptoms of fatigue measured using the Multidimensional Fatigue Symptom Inventory- short form (MSFI- SF) at baseline, 6 weeks, 12 weeks and 6 months 6. Symptoms of anxiety and depression measured using the Hospital Anxiety and Depression scale (HADS) at baseline, 6 weeks, 12 weeks and 6 months 7. Belief in their ability to complete incremental 5-minute periods of walking, measured using the Self-Efficacy for Walking Scale at baseline, 6 weeks, 12 weeks and 6 months 8. Different types of motivation for physical activity measured using the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) at baseline, 6 weeks, 12 weeks and 6 months 9. Enjoyment of physical activity measured using the Physical Activity Enjoyment Scale (PACES) at baseline, 6 weeks, 12 weeks and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed