Clinical trial · Interventional
Integrative Approaches for Cancer Survivorship 2: Project 2
Developing a Health Education Intervention for Breast Cancer Survivorship
NCT02897544CI-TRIAL-00037440IACS2completedN/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 develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Manualized Health Education Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health Education Intervention
- description
- Study participants will attend Health Education sessions led by health educators over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.
- interventionNames
- Behavioral: Individualized Manualized Health Education Intervention
Primary outcomes (1)
- measure
- Change in quality of life over 6 months
- timeFrame
- Baseline, 3 months, 6 months
- description
- The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.
Secondary outcomes (6)
- measure
- Change in fatigue over 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * Having received chemotherapy as part of their primary therapy for breast cancer * Be in complete remission * Aged 18 years or older * Able to read, write, and understand English * Karnofsky Performance Status (KPS) greater than or equal to 60 * Have impaired quality of life * Ability to give informed consent Exclusion Criteria: * Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary. * Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. * Patients on adjuvant hormone therapy for less than 2 months * Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
References
Publications (0)
Data not yet available
No reference posted for this study.