Clinical trial · Interventional
Pain and Fatigue Study
Family Home Care for Cancer - A Community-Based Model
- 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)
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care. When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following: 1. The primary outcome--total number of symptoms reported; 2. The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and 3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.
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 |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-nurse coach | Behavioral | — | UNRESOLVED |
| Nurse | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nurse
- description
- Receives symptom management assistance from an oncology nurse via the telephone
- interventionNames
- Behavioral: Nurse
- type
- EXPERIMENTAL
- label
- Non-nurse coach
- description
- Receives symptom management assistance from a non-nurse coach via telephone
- interventionNames
- Behavioral: Non-nurse coach
Primary outcomes (1)
- measure
- Primary patient outcome
- description
- Lower reported severity of symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 21 years of age or older * solid tumor cancer diagnosis * receiving chemotherapy treatment * advanced cancer * family caregiver Exclusion Criteria * Emotional or psychology disorder for which patient is receiving treatment * does not speak English * does not have access to a telephone * difficulty hearing on the telephone
References
Publications (0)
Data not yet available