Clinical trial NCT06749964: An N-of-1 Trial of an Internet-delivered CBT Program Based on the Psychological Flexibility Model of Chronic Pain for Cancer-related Difficulties
Official title: Cancer-related Pain and Associated Difficulties: Using Ecological Momentary Assessment and N-of-1 Trial Methods to Adapt and Pilot Test an Internet-delivered CBT Program Based on the Psychological Flexibility Model of Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Cancer-related Pain
Keywords: chronic cancer-related pain
psychological flexibility
internet delivered cognitive behavioral therapy
n-of-1 design
mediation
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study applies a nonconcurrent, randomised baseline length, single case experimental design (SCED) where each participant serves as their own control. Participants are randomized to a 7 - 21 days long Baseline Phase wherein they receive no intervention, immediately followed by the 5-week Treatment Phase, and then a 3-month Follow-Up Phase.
Primary purpose: TREATMENT

Brief summary: Chronic pain is a commonly occurring complication of cancer and can have negatively impact day-to-day functioning and well-being. The recommended treatment for all forms of chronic pain is cognitive behavioral therapy (CBT). However, access to this treatment in primary and specialist care is limited, including access to specialist pain clinics that do not routinely accept people with cancer-related pain. In addition, we know from clinical trials of pain-focused CBT that the symptom presentation of patients can vary greatly and may require interventions that are more tailored to their specific needs.

The primary objective of the research is to test the feasibility, acceptability and preliminary efficacy of an internet-delivered, therapist-assisted, intervention for chronic pain with adults suffering from chronic cancer-related pain. The intervention is a form of CBT called Acceptance Commitment Therapy (ACT) and is based on the psychological flexibility model of pain. Psychological flexibility refers to an overall pattern of persistent behaviors characterized by a present-moment focus, acceptance rather than avoidance of distressing symptoms, and engagement with one's core values and goals. The intervention aims to improve overall functioning and well-being by helping participants to develop persistent patterns of behavior that align with with their core values and goals (e.g., personal, family, social, health, occupational) despite the presence of pain and other distressing symptoms.

To achieve this aim, an existing pain-focused, internet-delivered, psychological flexibility based intervention was modified specifically for cancer-related pain with input from cancer patients and survivors. The 8-session, online intervention involves a mixture of written, audio, and videotaped materials, and instructions for experiential exercises, all of which are designed to reduce unhelpful coping behaviors and to increase psychological flexibility. Participants receive written support (and ask questions) from a therapist via the online platform where the intervention is hosted. Where necessary, participants may also access a limited number of face-to-face meetings (online) with their therapist. During the treatment phase, information from daily diary recordings (via smartphone) are used to provide individualized support to participants in the form of text messages from a therapist via the online platform. Where necessary, a limited number of face-to-face sessions (online) with a therapist are scheduled.

Detailed description: The number of long-term cancer survivors is steadily increasing due to advances in early detection and treatment. At the same time, the number of cancer patients and survivors requiring treatment for complications of cancer is also increasing. Among the most common of these complications is chronic pain, defined as pain that persists for three or more months, and that develops either as a consequence of the disease or its treatments. Chronic cancer-related pain is associated with an increased risk of fatigue, emotional distress, occupational difficulties, increased healthcare usage, and needing assistance with activities of daily living. There are now a variety of medications that can be prescribed during cancer treatment or palliative care to reduce acute pain. However, longer-term use of these medications for chronic pain brings an increased risk of other health and behavioral difficulties. International guidelines recommend cognitive behavioural therapy (CBT) for chronic pain. However, it is widely recognized that chronic pain in cancer patients and survivors is under treated in primary and specialist care settings. This is partly due to the limited availability of therapists who can provide pain-focused CBT programs and specialist pain rehabilitation clinics not routinely accepting individuals with cancer-related pain.

One evidence-based and recommended variant of CBT for chronic pain is Acceptance and Commitment Therapy (ACT). ACT works to increase "psychological flexibility" through experiential exercises focused on developing a present-moment focus (mindfulness), openness to rather than avoidance of distressing symptoms, awareness of one's core values and goals, and commitment to behaving in line with these values/goals. Studies have found that cancer patients and survivors who are higher in psychological flexibility have greater overall well-being and functioning despite the presence of chronic cancer-related pain and associated difficulties. However, there is as yet limited research investigating the efficacy of ACT for cancer-related pain.

Given the large and increasing number of individuals diagnosed with cancer each year, and that up to 40% will develop chronic cancer-related pain, there is a need for effective treatments that can be accessed outside of specialist pain clinics. Digitally delivered interventions, either via smartphones, computers or teleconferencing, often collectively referred to as mobile-health interventions (mHealth), are seen as a cost-effective method for increasing access treatments for individuals with pain arising from diverse difficulties, including cancer. Also, there is now widespread recognition that to improve the efficacy of pain-focused CBT, clinicians and researchers need to develop methods for personalizing the treatment interventions to better reflect the variety of clinical presentations of pain patients.

The main objective of this study is to test the feasibility, acceptability, and preliminary efficacy of an internet-delivered, therapist-assisted, ACT intervention for adults suffering from chronic cancer-related pain and associated difficulties. Specifically, the investigators aim to test:

1. whether the intervention is feasible and acceptable;
2. using each participant as their own control, to test the efficacy of the intervention for the primary (pain interference) and secondary outcomes (pain intensity, fatigue, fear of cancer recurrence, depression, anxiety, overall functioning, well-being, and psychological flexibility) at the individual and group level;
3. whether treatment gains are maintained at a 3-month follow-up; and
4. whether outcomes are mediated by changes in psychological flexibility.

To achieve the project's goals, a non-concurrent, randomized, multiple-baseline across participants, single case experimental design will be used. During the baseline and treatment phases, participants complete twice-daily recording of symptoms, functioning and psychological flexibility via a smartphone-based application. During the treatment phase, data from these recordings is used by an online therapist to make suggestions via text to the patient on the use of specific exercises within the intervention.

Eligibility criteria: Inclusion Criteria:

* Current or previous former cancer diagnosis;
* Recurring cancer-related pain;
* Aged 18 years or older;
* Living in Sweden;
* Fluent in Swedish;
* Possession of a smartphone where they can download the application necessary for the daily diary recordings;
* Access to a device with internet access to receive the intervention;
* Not receiving another psychological treatment.

Exclusion Criteria:

- Not meeting any of the above inclusion criteria.

Primary outcomes:
measure: Pain interference
timeFrame: From enrollment to the end of treatment at 6-8 weeks, and at month 5.
Secondary outcomes:
measure: Pain severity
timeFrame: From enrollment to the end of treatment at 6-8 weeks, and at month 5.
measure: Fatigue severity and interference
timeFrame: From enrollment to the end of treatment at 6-8 weeks, and at month 5.
measure: Fear of cancer recurrence
timeFrame: From enrollment to the end of treatment at 6-8 weeks, and at month 5.
measure: Depression
timeFrame: At enrollment, at month 2 and at month 5.
measure: Anxiety
timeFrame: At enrollment, at month 2 and at month 5.
measure: Well-being
timeFrame: At enrollment, at month 2 and at month 5.
measure: Psychological flexibility
timeFrame: From enrollment to the end of treatment at 6-8 weeks, and at month 5.
measure: Overall functioning
timeFrame: Up to 6-8 weeks.
measure: Mood
timeFrame: Up to 6-8 weeks.
measure: Subjective change
timeFrame: At month 2.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Sean Perrin, PhD
role: PRINCIPAL_INVESTIGATOR
References: