Advanced Cancer Clinical Trial
Official title:
Use of Patient-centered Self-administered Acupressure for Fatigue Management in Chinese Advanced Cancer Patients: A Randomized Wait-list Controlled Trial
OBJECTIVE: To evaluate the effect of a patient-centered self-administered acupressure intervention on fatigue, sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, and health-related quality of life among Chinese advanced cancer patients. HYPOTHESIS TO BE TESTED: Upon intervention completion, the intervention group will exhibit lower levels of fatigue, pain, fatigue-sleep disturbance-pain symptom cluster severity, and psychological distress and higher levels of sleep quality and health-related quality of life than the wait-list control group. DESIGN and SUBJECTS: A randomized wait-list controlled trial with intervention and wait-list control groups. A total of 30 Chinese advanced cancer patients who screen positive for moderate/severe fatigue with symptoms of insomnia and/or pain will be recruited. STUDY INSTRUMENTS: Chinese versions of the Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy - General, and a demographic questionnaire. INTERVENTION: A 4-week patient-centered self-administered acupressure intervention comprising 17.5 hours of individual training and self-practice. MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, psychological distress, health-related quality of life, actigraphy. DATA ANALYSIS: Linear mixed-effects models to assess between-group differences in outcome measures post-intervention and changes between data collection points, as well as whether the between-group differences vary across time. EXPECTED RESULTS: The proposed patient-centered self-administered acupressure intervention is useful for alleviating the fatigue and related symptoms experienced by Chinese advanced cancer patients.
The prevalence and impacts of fatigue and related symptoms in cancer patients have been clearly demonstrated in the literature, which also emphasizes the need for evidence-based interventions targeting symptom management in such advanced patients. The main challenge is identifying an intervention that is not only effective in managing cancer-related symptoms but is also feasible, acceptable, and safe for this patient group. The proposed study aims to test the effects of a patient-centered self-administered acupressure intervention on fatigue management for Chinese advanced cancer patients using the robust study design of a randomized, wait-list controlled trial. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
| Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
| Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
| Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
| Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT01901237 -
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
|
N/A |