Clinical trial · Observational
A Survivorship Care Plan for Gynaecological Cancer Patients
Does a Post Treatment Survivorship Care Plan Improve Gynaecological Cancer Patient's Quality of Life and Self Efficacy? A Mixed Methods Pilot Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research on best models of posttreatment rehabilitation support for women posttreatment for gynaecological cancer is limited. The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life. Secondary objectives are to determine any additional benefit to general selfefficacy, generic health related quality of life or social and health economics for patients who have completed treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives of the intervention. The study will be open to patients attending the outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed treatment for Stage I or II gynaecological cancer. They will report that they have experienced a physical or psychosocial need resulting from the disease or its treatment; be aged over 18 years and be willing and able to articulate their needs. The study will last for six months for each participant. It will involve completing questionnaires and attending two extra rehabilitation appointments to develop a survivorship care plan at the hospital may also include attending for an interview about being involved in the study for those randomised to the intervention group
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Participants randomised to the control group would receive usual rehabilitation care via the existing referral pathways.
- label
- Intervention Group
- description
- Participants randomised to the intervention group will be offered two rehabilitation appointments at three month intervals. They will complete the screening tool, the Distress (Concerns) Thermometer before the first appointment; this will be reviewed after three months. Appointments will make use of communication skills recognised to promote motivation via self-efficacy. Self efficacy is a person's belief in their ability to achieve a goal. Their sense of mastery will influence their behaviour, their perception of stress and the effort they put into achieving that goal.
Primary outcomes (1)
- measure
- Change in EORTC
- timeFrame
- 6 months
- description
- The primary endpoint will be the change from baseline to six months in EORTC global quality of life score. The mean change with 95% confidence interval will be evaluated for each arm. All patients will be included in an ITT analysis: patients with missing data at six months will be assumed to have a change of 0 points from baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Participants will: have a diagnosis of and have completed initial treatment for Stage I or II gynaecological cancer; * will have recently completed a treatment pathway with radical intent; * have received primary treatment at The Royal Marsden NHS Foundation Trust (RM); * report that they have experienced a physical or psychosocial need resulting from the disease or it's treatment; * be aged over 18 years; * be willing and able to articulate their needs. Exclusion Criteria: * Those eligible for end-of-life care, * those with metastatic disease * those that lack capacity to understand the purpose of the study and participate
References
Publications (0)
Data not yet available