Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04175639
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2019-11-21
Brief Title:
mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICAN-NC
Brief Summary:
The efficacy of a mobile health mHealth behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management The proposed projects objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training mPCST-Community designed to meet the needs of breast cancer patients with pain in medically underserved areas mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients community based oncology clinic by a remote therapist is extended to the patients home environment using simple mHealth technology and is low-literacy adapted The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group mHealth-Ed The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering Guided by strong preliminary data a randomized controlled trial will be used to pursue three specific aims 1 Test the extent to which the mPCST-Community intervention reduces pain fatigue disability and distress 2 Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain fatigue disability and distress and 3 To evaluate the cost-effectiveness of mPCST-Community For Aim 1 based on the study teams extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community it is expected that mPCST-Community will lead to decreased pain as well as fatigue disability and distress compared to mHealth-Ed For Aim 2 it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing For Aim 3 it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use participant and therapist time and health utilities as well as successful overall accrual high subject retention and high intervention adherence
Detailed Description:
Guided by extensive prior work the investigators have designed an innovative mHealth behavioral pain coping skills training PCST intervention to reduce pain and disability in cancer patients in medically underserved areas mPCST-Community Our prior work has tested PCST protocols through in-person sessions at major medical centers where resources and literacy levels are relatively high mPCST-Community is different and innovative it uses mHealth technology eg videoconferencing to decrease access barriers for patients in medically underserved areas The protocol is brief 4 sessions and delivered in the community clinic by a remote well-trained pain therapist Importantly this protocol has been carefully adapted for low literacy patientsBeverly Thorn PhD a nationally recognized expert in strategies for adapting pain coping interventions to low literacy medically underserved patients was instrumental in developing the mPCST-Community protocol mPCST-Community extends to the patients daily life through use of a simple mobile application that provides low literacy textaudio protocol summaries relaxation audio daily assessment and personalized feedback and coping messaging
The investigators propose a randomized controlled trial RCT to test the efficacy of the developed mPCST-Community protocol in breast cancer patients with pain receiving cancer care in medically underserved areas N180 The investigators have done careful and extensive pilot work to prepare for the proposed trial Our pilot work Journal of Psychosocial Oncology was conducted in breast cancer patients with pain in three medically underserved rural community clinics First focus group data 3 groups n19 were used to further refine the adapted protocol Second the mPCST-Community protocol was evaluated in a single-arm trial with 20 patients The invesitgators found high feasibility ie recruitment met low attrition and high adherence 90 completion and high acceptability Importantly impressive and positive pre- to post-intervention changes were found for pain severity t-252 p001gav062 30 change pain interference t-262p001 gav062 and self-efficacy for pain management t357 p00004 gav098 30 change8Study specific aims are
Aim 1Test the extent to which mPCST-Community reduces breast cancer patients pain severity primary outcome pain interference fatigue physical disability and psychological distress HypothesismPCST-Community will lead to decreases in these pain-related outcomes compared to a Health-Ed control condition
Aim 2Examine mediators through which mPCST-Community leads to benefits HypothesisThe effects of mPCST-Community on pain severity pain interference fatigue physical disability and psychological distress will be mediated by increased self-efficacy for pain management and decreased pain catastrophizing
Aim 3Evaluate the cost and cost-effectiveness of mPCST-Community Hypothesis mPCST-Community will be cost-saving or cost effective in terms of its incremental cost per quality-adjusted life-year from a societal perspective inclusive of healthcare intervention and patient-time costs Its sustainability will be further demonstrated by documenting successful accrual retention and protocol adherence
The investigators propose a randomized controlled trial RCT to test the efficacy of the developed mPCST-Community protocol in breast cancer patients with pain receiving cancer care in medically underserved areas N180 The investigators have done careful and extensive pilot work to prepare for the proposed trial Our pilot work Journal of Psychosocial Oncology was conducted in breast cancer patients with pain in three medically underserved rural community clinics First focus group data 3 groups n19 were used to further refine the adapted protocol Second the mPCST-Community protocol was evaluated in a single-arm trial with 20 patients The invesitgators found high feasibility ie recruitment met low attrition and high adherence 90 completion and high acceptability Importantly impressive and positive pre- to post-intervention changes were found for pain severity t-252 p001gav062 30 change pain interference t-262p001 gav062 and self-efficacy for pain management t357 p00004 gav098 30 change8Study specific aims are
Aim 1Test the extent to which mPCST-Community reduces breast cancer patients pain severity primary outcome pain interference fatigue physical disability and psychological distress HypothesismPCST-Community will lead to decreases in these pain-related outcomes compared to a Health-Ed control condition
Aim 2Examine mediators through which mPCST-Community leads to benefits HypothesisThe effects of mPCST-Community on pain severity pain interference fatigue physical disability and psychological distress will be mediated by increased self-efficacy for pain management and decreased pain catastrophizing
Aim 3Evaluate the cost and cost-effectiveness of mPCST-Community Hypothesis mPCST-Community will be cost-saving or cost effective in terms of its incremental cost per quality-adjusted life-year from a societal perspective inclusive of healthcare intervention and patient-time costs Its sustainability will be further demonstrated by documenting successful accrual retention and protocol adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None