Clinical trial · Interventional
An Online Psychosocial Intervention for Fear of Cancer Recurrence in Breast Cancer Survivors
- 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)
A total of 244 breast cancer survivors will be invited to participate in the randomized controlled trial. Breast cancer survivors who meet the inclusion criteria and provide digital informed consent will be included. Participants will be stratified and randomized by the severity of baseline fear of cancer recurrence and time since diagnosis. In the control arm, women will be treated as usual. In the intervention arm, women will be offered a six-weekly, 60 min, online mindfulness and acceptance intervention. An online questionnaire will be used to collect data at four time points: before the first group session, immediately after the intervention, three months, and six months post-intervention. Phone interviews exploring participants' experiences will be held immediately after the intervention with women of the intervention group.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fear of Cancer Recurrence | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online mindfulness and acceptance intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Online mindfulness and acceptance intervention
- description
- Participants of the intervention group will receive an intervention manual and videos. The duration of the intervention will be six weeks. Participants will be asked for a minimum time investment of 60 min per week. The intervention will be delivered via WeChat video call. The intervention will be conducted following the intervention manual to ensure consistency of intervention content that delivered.
- interventionNames
- Behavioral: Online mindfulness and acceptance intervention
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Participants of the control group will be received usual follow-up care including regular medical checkups, which may include a physical exam, blood tests, and imaging tests.
Primary outcomes (1)
- measure
- Fear of cancer recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * are over 18 years old * diagnosed with primary stage 0-III breast cancer * have completed primary cancer treatment within ten years (ongoing endocrine therapy is permitted) * have sub-clinical or clinical fear of cancer recurrence as defined by a score in the range of 13 to 21 or \> 21 on the fear of cancer recurrence inventory (FCRI) * have a smart-phone * can speak and read Mandarin Exclusion Criteria: * with cognitive impairment such as diagnosis of Parkinson's disease * have clinically diagnosed psychiatric disorder * are engaging in mindfulness and acceptance intervention
References
Publications (0)
Data not yet available