CONTEXT: Pain, fatigue, and sleep disturbance commonly co-occur in patients receiving treatment for advanced cancer. OBJECTIVES: A pilot randomized controlled trial was conducted to assess initial efficacy of a patient-controlled cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster. METHODS:Eighty-six patients with advanced lung, prostate, colorectal, or gynecologic cancers receiving treatment at a comprehensive cancer center were stratified by recruitment clinics (chemotherapy and radiation therapy) and randomized to intervention or control groups. Forty-three patients were assigned to receive training in and use of up to 12 relaxation, imagery, or distraction exercises delivered via an MP3 player for two weeks during cancer treatment. Forty-three patients were assigned to a waitlist control condition for the same two week period. Outcomes included symptom cluster severity and overall symptom interference with daily life measured at baseline (Time 1) and two weeks later (Time 2). RESULTS:Eight participants dropped out; 78 completed the study and were analyzed (36 intervention and 42 control subjects). Participants used the CB strategies an average of 13.65 times (SD=6.98). Controlling for baseline symptom cluster severity and other relevant covariates, it was found that the symptom cluster severity at Time 2 was lower in the intervention group (M(Adj)=2.99, SE=0.29) than in the waitlist group (M(Adj)=3.87, SE=0.36), F(1, 65)=3.57, P=0.032. Symptom interference with daily life did not differ between groups. No significant adverse events were noted with the CB intervention. CONCLUSION: Findings suggest that the CB intervention may be an efficacious approach to treating the pain, fatigue, and sleep disturbance symptom cluster. Future research is planned to confirm efficacy and test mediators and moderators of intervention effects.
RCT Entities:
CONTEXT: Pain, fatigue, and sleep disturbance commonly co-occur in patients receiving treatment for advanced cancer. OBJECTIVES: A pilot randomized controlled trial was conducted to assess initial efficacy of a patient-controlled cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster. METHODS: Eighty-six patients with advanced lung, prostate, colorectal, or gynecologic cancers receiving treatment at a comprehensive cancer center were stratified by recruitment clinics (chemotherapy and radiation therapy) and randomized to intervention or control groups. Forty-three patients were assigned to receive training in and use of up to 12 relaxation, imagery, or distraction exercises delivered via an MP3 player for two weeks during cancer treatment. Forty-three patients were assigned to a waitlist control condition for the same two week period. Outcomes included symptom cluster severity and overall symptom interference with daily life measured at baseline (Time 1) and two weeks later (Time 2). RESULTS: Eight participants dropped out; 78 completed the study and were analyzed (36 intervention and 42 control subjects). Participants used the CB strategies an average of 13.65 times (SD=6.98). Controlling for baseline symptom cluster severity and other relevant covariates, it was found that the symptom cluster severity at Time 2 was lower in the intervention group (M(Adj)=2.99, SE=0.29) than in the waitlist group (M(Adj)=3.87, SE=0.36), F(1, 65)=3.57, P=0.032. Symptom interference with daily life did not differ between groups. No significant adverse events were noted with the CB intervention. CONCLUSION: Findings suggest that the CB intervention may be an efficacious approach to treating the pain, fatigue, and sleep disturbance symptom cluster. Future research is planned to confirm efficacy and test mediators and moderators of intervention effects.
Authors: Andrea Barsevick; Susan L Beck; William N Dudley; Bob Wong; Ann M Berger; Kyra Whitmer; Tracey Newhall; Susan Brown; Katie Stewart Journal: J Pain Symptom Manage Date: 2010-06-18 Impact factor: 3.612
Authors: Paula Sherwood; Barbara A Given; Charles W Given; Victoria L Champion; Ardith Z Doorenbos; Faouzi Azzouz; Sharon Kozachik; Kim Wagler-Ziner; Patrick O Monahan Journal: Oncol Nurs Forum Date: 2005-11-03 Impact factor: 2.172
Authors: Colin A Espie; Leanne Fleming; James Cassidy; Leslie Samuel; Lynne M Taylor; Craig A White; Neil J Douglas; Heather M Engleman; Heidi-Louise Kelly; James Paul Journal: J Clin Oncol Date: 2008-06-30 Impact factor: 44.544
Authors: Charles Given; Barbara Given; Mohammad Rahbar; Sangchoon Jeon; Ruth McCorkle; Bernadine Cimprich; Andrzej Galecki; Sharon Kozachik; Albert Brady; Mary Jo Fisher-Malloy; Kathy Courtney; Elizabeth Bowie Journal: J Clin Oncol Date: 2004-02-01 Impact factor: 44.544
Authors: Alla Sikorskii; Charles W Given; Barbara Given; Sangchoon Jeon; Veronica Decker; David Decker; Victoria Champion; Ruth McCorkle Journal: J Pain Symptom Manage Date: 2007-07-09 Impact factor: 3.612
Authors: I-Chan Huang; Tara M Brinkman; Kelly Kenzik; James G Gurney; Kirsten K Ness; Jennifer Lanctot; Elizabeth Shenkman; Leslie L Robison; Melissa M Hudson; Kevin R Krull Journal: J Clin Oncol Date: 2013-10-14 Impact factor: 44.544
Authors: Christine Miaskowski; Andrea Barsevick; Ann Berger; Rocco Casagrande; Patricia A Grady; Paul Jacobsen; Jean Kutner; Donald Patrick; Lani Zimmerman; Canhua Xiao; Martha Matocha; Sue Marden Journal: J Natl Cancer Inst Date: 2017-01-24 Impact factor: 13.506
Authors: Kristine L Kwekkeboom; Lauren Tostrud; Erin Costanzo; Christopher L Coe; Ronald C Serlin; Sandra E Ward; Yingzi Zhang Journal: J Pain Symptom Manage Date: 2018-01-31 Impact factor: 3.612
Authors: Stephanie J Sohl; Gurjeet S Birdee; Sheila H Ridner; Amy Wheeler; Sandra Gilbert; Danielle Tarantola; Jordan Berlin; Russell L Rothman Journal: Int J Yoga Therap Date: 2016-01
Authors: JiYeon Choi; Leslie A Hoffman; Richard Schulz; Judith A Tate; Michael P Donahoe; Dianxu Ren; Barbara A Given; Paula R Sherwood Journal: J Pain Symptom Manage Date: 2013-07-12 Impact factor: 3.612
Authors: Melissa Mazor; Janine K Cataldo; Kathryn Lee; Anand Dhruva; Bruce Cooper; Steven M Paul; Kimberly Topp; Betty J Smoot; Laura B Dunn; Jon D Levine; Yvette P Conley; Christine Miaskowski Journal: Eur J Oncol Nurs Date: 2017-12-19 Impact factor: 2.398
Authors: Janae L Kirsch; Michael E Robinson; Christina S McCrae; Elizabeth L Kacel; Shan S Wong; Seema Patidar; Timothy S Sannes; Stephanie Garey; Jacqueline C Castagno; Deidre B Pereira Journal: Pain Med Date: 2020-01-01 Impact factor: 3.750