Image

An N-of-1 Trial of an Internet-delivered CBT Program Based on the Psychological Flexibility Model of Chronic Pain for Cancer-related Difficulties

An N-of-1 Trial of an Internet-delivered CBT Program Based on the Psychological Flexibility Model of Chronic Pain for Cancer-related Difficulties

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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

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.

Study details
    Chronic Cancer-related Pain

NCT06749964

Lund University

16 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.