Clinical trial · Interventional
A Mind-body Intervention to Improve Body and/or Self Image
A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial
NCT02531997CI-TRIAL-00030787completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine if hypnotic relaxation therapy is a more effective intervention for improving self-image in women who have been diagnosed with breast or gynecologic cancer when compared to progressive muscle relaxation therapy.
Conditions
Conditions (4)
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 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnotic Relaxation Therapy | Behavioral | — | UNRESOLVED |
| Progressive Muscle Relaxation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hypnotic Relaxation Therapy
- description
- Hypnotic relaxation will be performed in three sessions, two weeks apart, over 6 weeks. The hypnosis sessions will build on each other in terms of content.
- interventionNames
- Behavioral: Hypnotic Relaxation Therapy
- type
- OTHER
- label
- Progressive Muscle Relaxation (PMR)
- description
- The PMR will consist of progressive tensing and relaxing of the muscles from head to toe to a soothing sound of the participant's choosing.
- interventionNames
- Behavioral: Progressive Muscle Relaxation
Primary outcomes (1)
- measure
- Impact of Treatment Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * a history of any stage of breast or gynecologic cancer * reported a change in body/self-image since diagnosis and wish to improve it. Two screening questions will be used: Has body image or self-image changed in an unwanted way since the cancer diagnosis? (Answer must be yes.) Would the potential participant like to be able to do something to improve body image or self-image? (Answer must be yes.) * Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment * Performance status of 2 or better Exclusion Criteria: * Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, or schizophrenia as listed in the patient's medical history per Diagnostic and Statistical Manual for Mental Health-IV criteria in the chart and/or by self-report * Past history of sexual abuse. * Currently on 2 or more antidepressant therapies for mood disturbance of any kind. Past use is allowed, just not current use. * Currently on 2 or more anti-anxiety therapies. Past use is allowed, just not current use.
References
Publications (1)
- DERIVEDArring NM, Lafferty CK, Clark PM, Barton DL. The experience of women in a phase II trial of hypnosis and progressive muscle relaxation for body image: informing future research questions. J Psychosoc Oncol. 2024;42(1):148-158. doi: 10.1080/07347332.2023.2206406. Epub 2023 Apr 28. PMID 37114974