Clinical trial · Interventional
Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
NCT02495155CI-TRIAL-00023245PROSPECTcompletedN/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)
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.
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 |
| Fatigue | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROSPECT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Fatigue
- description
- Participants who have received treatment for early stage breast cancer and who experience fatigue, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
- interventionNames
- Behavioral: PROSPECT
- type
- ACTIVE_COMPARATOR
- label
- Treatment-related Pain
- description
- Participants who have received treatment for early stage breast cancer and who experience pain, rated at least a 4 on a scale of 0-10 during the previous week, per patient report. Participants will complete baseline symptom questionnaires, then complete an internet-based cognitive behavioral therapy program (PROSPECT) for 8 weeks, then repeat questionnaires.
- interventionNames
- Behavioral: PROSPECT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Stage 0-III invasive carcinoma of the breast * Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment. * Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment. * Must report at least one of the following: 1. Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) 2. Insomnia in the week prior to enrollment 3. Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain) * Has access to and is able to operate a computer with internet access. * Able to read and understand English. * Willing and able to sign an informed consent document. Exclusion Criteria: \- Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
References
Publications (0)
Data not yet available
No reference posted for this study.