2 Clinical Trials for Various Conditions
Pain in cancer patients is estimated to be as high as 90% and results in physical and psychological disability. Behavioral interventions that increase patients' confidence in their ability to manage their pain have been shown to be beneficial. Behavioral interventions for cancer pain teach patients how their thoughts and feelings can influence their pain and specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite guidelines recommending such interventions be used in the care of cancer patients with pain, they are not routinely used. A critical barrier to the use of behavioral interventions is that patients have difficulties attending appointments which are typically offered at the medical center during normal business hours. Mobile health (mHealth) technologies provide new opportunities to decrease such barriers. The investigators have developed a new mHealth approach that may increase the use of behavioral cancer pain interventions and ultimately lead to greater use of interventions that can decrease pain and disability. The investigators propose to test an approach that uses mHealth technologies to deliver a behavioral cancer pain intervention to patients in their home using a tablet computer (e.g., iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping skills training intervention protocol (PCST-trad) at the medical center. The investigators will test whether the mPCST is more accessible to patients than PCST-trad. The investigators expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more patients will complete it in a timely manner; b) create less burden meaning it is easier for patients physically, emotionally, and financially to participate; c) increase engagement meaning that patients will practice skills more and have more understanding of the material; and d) be more overall acceptable to patients. the investigators also expect that patients who find this intervention more feasible, less burdensome, more engaging, and more acceptable will be more likely to experience decreased pain, physical disability, and psychological disability, and increased confidence in their ability to manage their pain. The investigators' goal is to use mHealth technologies to facilitate wide-spread use of behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain interventions will particularly benefit patients living far from medical centers (e.g., rural), experiencing cancer-related physical challenges, and facing other practical barriers (e.g., transportation, work) to in-person interventions. These outcomes could lead to future work evidencing that mHealth behavioral interventions could be applied to other areas of quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with persistent pain (e.g., arthritis).
Persistent pain is a major challenge for patients who undergo hematopoietic stem cell transplant (HSCT) and is related to more fatigue, more physical disability, poorer quality of life, and poorer medical adherence. There is a need to examine strategies for managing pain in HSCT patients that can complement existing analgesic regimens. Strong evidence suggests that cognitive and behavioral factors play an important role in HSCT patients' ability to manage their pain. The investigator has found that HSCT patients having low levels of confidence (i.e., self-efficacy) in their ability to control pain and high use of maladaptive coping strategies (i.e., pain catastrophizing) experience increased pain and disability. A psychosocial intervention that modifies patients' cognitive and behavioral pain coping strategies may benefit HSCT patients. Protocols, particularly Pain Coping Skills Training (PCST), have been developed for reducing pain and improving quality of life in patients with persistent pain. However, HSCT patients with persistent pain face a number of unique challenges that must be considered when applying a PCST protocol. The investigator proposes to develop and test a Mobile Health Pain Coping Skills (mPCST) protocol for HSCT patients with persistent pain to meet the challenges of HSCT patients with pain as they transition from hospital based care to their home environment. The first aim of this study is to use an iterative development model to design a mPCST intervention protocol for HSCT patients that targets increasing self-efficacy for pain control and decreasing pain catastrophizing. The study team will use focus groups with patients and HSCT providers to guide development along with user testing with HSCT patients having pain. The second aim of this study is to use a small randomized controlled trial to examine the feasibility, acceptability, and engagement in the developed mPCST protocol. The third aim is to obtain an estimate of the effect size of the developed mPCST protocol on decreased pain, pain disability, physical disability, and adherence to post-transplant lifestyle recommendations impacted by pain when compared to a standard care control condition. Proposed innovative features of the mPCST protocol that will be developed include: extensive input from PCST and HSCT experts and HSCT patients with pain; an initial session prior to discharge with subsequent sessions occurring at home via video-conferencing; incorporation of strategies to decrease the impact of pain on adherence to critical post-transplant lifestyle recommendations; a real-time daily assessment system with subsequent tailored feedback. If the developed mPCST protocol demonstrates feasibility, acceptability, engagement, and promising effect sizes to influence pain and other indices of quality of life, a larger NIH grant will be sought to examine this protocol in a larger sample of patients, test the protocol against an active treatment, and investigate a broader array of outcomes (e.g., medication adherence). This mPCST protocol could also be examined in other patient populations with pain facing similar challenges (e.g., live far from medical center, travel limitations).